Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatment of Helicobacter Pylori Infection

Tanta University

Status: Enrolling

Conditions: Treatment; Helicobacter Pylori Infection; Proton Pump Inhibitor; Bismuth Based Quadruple Therapy; Potassium-Competitive Acid Blocker

Treatments: Drug: Potassium-Competitive Acid Blocker; Drug: Proton Pump Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT07165444

36264PR1285/7/25

Details and patient eligibility

About

This study aims to compare the eradication rate, safety, and patient adherence between potassium-competitive acid blockers (P-CABs) and proton pump inhibitor-based bismuth quadruple therapy in patients with Helicobacter pylori infection.

Full description

Helicobacter pylori (H. pylori) is a spiral-shaped, Gram-negative bacterium that colonizes the stomach lining and is considered one of the most prevalent chronic infections globally.

Bismuth-based quadruple therapy (proton pump inhibitor, bismuth, metronidazole, and tetracycline) is considered an effective alternative in cases of antibiotic resistance. This regimen achieves high eradication rates, even in areas with dual clarithromycin and metronidazole resistance.

Potassium-competitive acid blockers (P-CABs), such as vonoprazan, provide rapid, consistent, and strong acid suppression regardless of the CYP2C19 genotype.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥18 years.
• Both sexes.
• Confirmed Helicobacter pylori infection by stool antigen (3rd-gen ELISA) or urea breath test (UBT).
• No prior eradication therapy.

Exclusion criteria

• Prior Helicobacter pylori treatment.
• Use of antibiotics, proton pump inhibitor, or bismuth in the prior 4 weeks.
• Gastric surgery history.
• Major organ failure.
• Pregnancy or lactation.
• Known allergy to study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

320 participants in 2 patient groups

B-CAP group

Experimental group

Description:

Patients will a 10-day course of bismuth, metronidazole, tetracycline four times daily, and vonoprazan 20 mg twice daily.

Treatment:

Drug: Potassium-Competitive Acid Blocker

PPI group

Active Comparator group

Description:

Patients will receive a 10-day course of bismuth, metronidazole, tetracycline four times daily, and rabeprazole 20 mg twice daily.

Treatment:

Drug: Proton Pump Inhibitor